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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, contact, (disposable)
Regulation Description Soft (hydrophilic) contact lens.
Product CodeMVN
Regulation Number 886.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 32 32
2021 24 24
2022 18 18
2023 24 24
2024 25 25
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 82 82
Insufficient Information 19 19
Material Split, Cut or Torn 12 12
Patient-Device Incompatibility 6 6
Improper or Incorrect Procedure or Method 6 6
Break 3 3
Product Quality Problem 3 3
Defective Device 3 3
No Apparent Adverse Event 2 2
Entrapment of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Expiration Date Error 2 2
Material Rupture 2 2
Use of Device Problem 1 1
Difficult to Remove 1 1
Packaging Problem 1 1
Expulsion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 42 42
Eye Pain 35 35
Eye Infections 32 32
Red Eye(s) 27 27
Blurred Vision 17 17
Eye Injury 17 17
Keratitis 17 17
Corneal Scar 13 13
Corneal Edema 13 13
Corneal Abrasion 13 13
Corneal Infiltrates 12 12
Visual Impairment 10 10
Unspecified Infection 8 8
Foreign Body Sensation in Eye 7 7
Conjunctivitis 7 7
Excessive Tear Production 6 6
Erosion 6 6
Neovascularization 6 6
Headache 5 5
Loss of Vision 5 5
Burning Sensation 5 5
Discomfort 5 5
Inflammation 5 5
Dry Eye(s) 4 4
Bacterial Infection 4 4
Hyphema 4 4
Visual Disturbances 4 4
Acanthameba Keratitis 4 4
Pain 4 4
Iritis 3 3
Ulcer 3 3
Swelling/ Edema 3 3
Fluid Discharge 3 3
Skin Inflammation/ Irritation 3 3
Corneal Stromal Edema 3 3
Purulent Discharge 3 3
Reaction 2 2
Abscess 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Irritation 2 2
Intraocular Pressure Decreased 2 2
Local Reaction 2 2
Eye Burn 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 2 2
Halo 2 2
Hyperemia 2 2
Itching Sensation 2 2
Device Embedded In Tissue or Plaque 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperVision, Inc. II Mar-26-2025
2 Johnson & Johnson Vision Care, Inc. II Apr-17-2020
3 Ontact Inc II Jul-05-2024
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